Posts Tagged ‘baby’

Instant detection of pregnancy and of Early Pregnancy Loss, EPL – the adversary of Trying To Conceive, TTC – especially after age 25

November 11, 2010

Early Pregnancy Loss is also known as #stillbirth or #miscarriage, or Early Embryonic Mortality (EEM), and the Ovulona™ is a tool of evidence-based personalized medicine.

After the optimum fertility age of the early twenties, achieving motherhood gets more difficult. It becomes even more essential than before to know your three fertile days, during which – and only during which – conception can occur.

The simple basic principle is: Fertility status detection must be easy and reliable. PLUS early pregnancy detection is really important, and it should be built-in, an integral part of the conception-aiding tool.

Why? Because:

1) early in pregnancy the conceived baby would be harmed by some of the medications taken by the woman, e.g. by a psychiatric medication with teratogenic effect (harmful to the fetus, causing a congenital disorder);

and 2) because of the annual 600,000 miscarriages – per CDC statistics – out of the 6 million US births, which means that at least some 10% of pregnancies are lost to early pregnancy loss (EPL), miscarriage, stillbirth.

Many EPLs go unnoticed. The EPL is a part of the TTC [Trying To Conceive] or subfertility/infertility problem. Our Ovulona monitor of FOLLICULOGENESIS IN VIVO™ is the prospective solution for managing the problem.

The Ovulona™ detects the 3 fertile days for conception, and it will also automatically detect pregnancy immediately upon conception. Similar to early pregnancy loss — its detection is the inverse of pregnancy detection, which both involve the follicular waves. Like this:

Follicular waves disappear = pregnancy detected

versus

waves reappear in early pregnancy =  early pregnancy loss detected.

Furthermore, the cyclic profile data captured by the Ovulona can be used by your healthcare provider to assess what is going on, and provide more effective help.

DIFFICULT USE OF EXISTING OPKs [Ovulation Prediction Kits] is shown in the following tweet by a @WannaBeMom: “1st month using opk. Do the lines usually start light and then get darker day by day or do they ever go back & forth b4 ovulation?”

Our electronic device will take the WannaBeMoms into a different world of baby-making.

Honey is Sweeter than Blood by Salavador Dali, 1941

Honey is Sweeter than Blood by Salavador Dali, 1941

For a woman in her 30s who has had a miscarriage or even two or three, “any delay in attempting conception could further decrease the chances of a healthy baby”, says CNN reporting on a medical study, http://www.cnn.com/2010/HEALTH/08/05/miscarriage.try.again.asap/ .

Study: Women who conceive within six months of miscarriage reduce risk of another.”

November 2016 review and meta-analysis (data on more than a million women): “With an Inter Pregnancy Interval of less than 6 months, the overall risk of further miscarriage and preterm delivery  were significantly reduced.”

These are fundamental principles.

And another principle, not brought up by the CNN or by the study itself, is that a tool for monitoring the early stage of pregnancy for EPL is most desirable. We’d say, mandatory. The Ovulona device monitors (or tracks the process of) folliculogenesis in vivo, which includes the follicular waves that occur after ovulation. The waves disappear upon conception because the reproductive system does not go into another menstrual cycle – it’s pregnant.

In case of EPL, Early Pregnancy Loss (miscarriage), the waves will come back. Early Pregnancy Loss, or Early Embryonic Mortality, is quite a common sad experience of many of us.

The essential point made here is that the woman’s and her physician’s decisions should be guided by the folliculogenesis cyclic profile (and/or its distortion due to distress of any kind). The woman and her doctor should not make decisions or pass recommendations working in the dark, and the data, on which any decision should be based, must be personal to the given patient.

That’s what the Ovulona from bioZhena is for. Personalized medicine. Evidence based medicine.

Automatic pregnancy detection is inherent in the Folliculogenesis In Vivo™ cyclic profile (follicular waves disappear).

This is a screen shot of one of my narrated slides about “what’s going on here” – view (and hear) the slide at https://biozhena.files.wordpress.com/2015/07/single-slide-unprecedented-wealth-of-info-narrated.pps.

Note specifically that: The follicular waves, which occur after ovulation [when the body prepares for the next menstrual cycle], cannot remain in place after fertilization succeeds and conception takes place [because the post-ovulation regime change is even more profound]. That is the principle of instant detection of pregnancy. As opposed to the waiting for the HPT [Home Pregnancy Test] result.

HCG or Human Chorionic Gonadotropin laboratory signature

HCG or Human Chorionic Gonadotropin laboratory signature of the biomarker – detected in a pregnant woman’s urine about 2 weeks into her pregnancy by a HPT home-use urine test – as a color change (into which color the HPT reduces the illustrated complex lab signature)

Should the conceptus [product of conception, early embryo] be lost to EEM, Early Embryonic Mortality (miscarriage), the follicular waves come back to be seen by the Ovulona. That’s the principle of early detection of the miscarriage, and of detecting the return of the non-pregnant condition.

Trying to conceive again should be based on the personal FIV™ [FOLLICULOGENESIS IN VIVO] cyclic profile data generated by the woman trying to have a baby. This is a principle of evidence-based medicine. Personalized medicine.

Entre Les Trous De La Memoire by Appia

The Ovulona is intended to help people such as those writing in a forum as follows:

My partner and i started trying for a baby in jan And Concieved in the first month. Unfortunately in march at 8 weeks I had a miscarriage. We have been trying since with no luck. Could something be wrong. Please help this is really getting me down. http://www.netdoctor.co.uk/interactive/discussion/viewtopic.php?t=57881&f=5

We got pregnant the first cycle with both my ds and dd. I am most likely moving to cycle #11 with this baby. We did conceive on the second cycle of trying with baby #3 but we miscarried a week later. Nothing since then. I’m not sure why this time is taking so much longer. http://www.mothering.com/discussions/showthread.php?p=16029816

Can anyone advise? My daughter has been trying to get pregnant for several years. Her husband is fine. My daughter has now been asked to go for a scan which scared the life out of me (you automatically think something is horribly wrong). Can someone tell me what the scan is about – what sort of scan is it? http://www.netdoctor.co.uk/interactive/discussion/viewtopic.php?t=31528&f=5

The information contained in the folliculogenesis cyclic profile, as illustrated in the slide captured above, is meaningful and can help the healthcare provider to answer questions such as these.

Advertisements

Major studies decades ago revealed variability of menstrual cycles

March 10, 2010

But people are still naïve about the basic cause of the difficulty to achieve pregnancy

Sex education at school, its quality or otherwise, is likely to have much to do with fertility problems later in life. Many women (men, too, of course) can use the  keyboard with all their fingers (as well as their thumbs!) but have poor understanding of the basic functioning of their reproductive system.

colonial classroom

colonial-classroom.jpg

That ignorance is well known, and is underlying the fertility problems. You should see the pregnancy doctors’ tweets – replying to some incredible questions, and then the talk of various mysteries!

A shining example is this tale of “mysterious conception”. For the whole story see the Alphabet of bioZhena under M, “Mysterious conceptions (OR THE NONEXISTENCE THEREOF)” on page 34 or thereabout, from which I cite:

QUOTE:  It appears that we must dwell on this topic, because of stories and notions propagated in various pertinent circles. This writing has been prompted by page 176 in the excellent 1999 book “Woman” by Nathalie Angier, where the Pulitzer laureate relates the story of the mysterious conception of her only child. Mysterious, because it occurred, she believes and makes her readers believe, outside of ovulation and of the fertile window.

The reason for this entry in the Alphabet of bioZhena is that there is NO SUCH THING AS MYSTERIOUS CONCEPTIONS, there is only lack of information, or ignorance of the facts. We might say, intellectual misconceptions lead to “mysteries” in terms of conception, of babies conceived supposedly when conception was biologically impossible, and vice versa, some women have difficulties conceiving for the same fundamental reason. We shall use Ms. Angier’s case to make this point. UNQUOTE.

To drive the point home, here is an excerpt from John J. McCarthy, Jr. and H.E. Rockette, “Prediction of ovulation with basal body temperature”, Journal of Reproductive Medicine, Volume 31 (No.8), Supplement, 742 – 747, 1986.

Referencing particularly large studies from 1967 and 1977, these BBT experts had this to say all those years ago (and never mind their “prediction” in the cited title whereas the BBT is well known to be no predictor):

QUOTE:  Cycle regularity is often assumed by both women and their physicians. The suggestion, that the BBT graph of the previous cycle can be used to identify the day of ovulation in the current cycle, requires nearly absolute cycle regularity. [However, note this:] The data collected by 1,085 women, who provided at least 6 or more charts each, were studied for cycle length variability. … The cycle length range was more than five days for 56% of the women who submitted 6 graphs, and for 75% of those with 12 graphs. … Absolute regularity was not demonstrated in as few as six cycles. Even when the cycle length that deviated the most was eliminated, less than 1% (8 of 1,085 women) had no variation in cycle length. When the number of cycles was extended to 12, no woman had variability of less than two days in cycle length. END OF QUOTE.

In real life, you realize, no cycle can be eliminated from the experience, and every day matters. Two days are very likely to make the difference between conception and the lack of it. And/or cause an unwanted pregnancy, for that matter.

middendorf_on_the_ball.jpg

Middendorf  – On the ball

The above findings are therefore the basis on which we can say quite categorically that nobody is as regular as a metronome (and nobody conceives in an anovulatory cycle), that there is no such thing as absolute regularity, whether 28 days or otherwise.

If you are in the sub-fertile category of people finding it difficult to become pregnant, you are likely to have cycle variability of more than 5 days over those months of your fruitless efforts that define your category. More likely than being one of the 0.74% of the population with no variation in cycle length, which under ideal conditions may also mean no variation in the time of ovulation. Persistent monitoring is well advised.

About the Added Bonus of Folliculogenesis Monitoring – Automatic Pregnancy Detection

January 10, 2010

.

It will really be advisable for women to use the Ovulona™ personal fertility monitor as advocated. Whether pregnancy is hoped for or pregnancy-avoidance is the purpose, diligent routine use of the Ovulona will bring benefits.

What benefits? Not only the correct scientific reckoning of the expected period of gestation (usually spoken of as the EDD or EDC) but also the subject of this article: The automatic immediate detection of pregnancy, which is built into the bioZhena process of menstrual cycle (folliculogenesis) monitoring.

See and hear about this in the narrated slide at https://biozhena.files.wordpress.com/2016/11/single-slide-narrated-best-wealth-of-info-in-menstrual-cycle-profile-signature.pps . Here is an image of the slide:

wealth-of-information-inherent-in-cyclic-profile-signature

We expect that the personal cervix monitoring will be continued after conception has been detected – whether planned or unplanned – for the reason of watching out for or guarding against the possibility of early pregnancy loss (EPL).

Immediate detection

The detection of EPL is based on the understanding of the post-ovulation part of the menstrual cyclic profile signature. In the event of an EPL, the menstrual cyclic profile (which cannot physiologically continue after conception and/or implantation occurs) is logically expected to come back, alerting the woman to try getting pregnant again as soon as possible. This urgency is to reduce the probability of recurring spontaneous abortion as documented in medical literature.

As a 2010 study concluded: Women who conceive within six months of an initial miscarriage have the best reproductive outcomes and lowest complication rates in a subsequent pregnancy. You can read a CNN article about the British Medical Journal published study at http://www.cnn.com/2010/HEALTH/08/05/miscarriage.try.again.asap/ . We cite the original BMJ publication at the very end of this post.

“Ask Medical Doctor” [http://www.askmedicaldoctor.com ] is a web site that provides numerous examples where it follows that our Ovulona™ personal fertility device will be just what the customer needs. And her OBGYN, too.

As an example, here is a posted question (courtesy of @pregnancydoc tweet) [http://www.askmedicaldoctor.com/medical/doctor/index.php?xq=63935 ]:

“I quit the nuva ring at the end of november, and had a short cycle. I was only on it for a month. My husband an I are trying to conceive. Last week I had a blood pregnancy test, which was negative. As well as the week before. Now I’m almost a week late. I’ve also experienced a little bit of breast tenderness, stomach tenderness, and lower back pain. what’s up?”

Answer by Dr.Bhumika Aggarwal on Fri 08, Jan 2010 10:33pm:

“Hi, Yes you could be pregnant. The only way to know the confirmed cause is a clinical examination by an OBG specialist and if required an ultrasound examination. You could take a urine pregnancy test at home – that would only help a week after you have missed your periods. You should get a blood test for beta HCG levels which would confirm or rule out a pregnancy. This is confirmatory for pregnancy in cases where the urine pregnancy test kit is not helpful. It would be best to consult your doctor without any delay. Regards.”

Commenting on the Ovulona advantage

The above case is not unusual, including the fact that, after quitting hormonal contraception, the menstrual cycle(s) will tend to be short, out of whack. More to the point, however, is that, with the routinely used Ovulona, pregnancy will be detected immediately, by the disappearance of the follicular waves normally appearing in the luteal phase of the cycle [the days after ovulation], whether the cycle is short, long or what have you.

Where the physician talks about the urine and blood pregnancy testing is where it gets interesting. When Dr. B. A. writes, “that would only help a week after you have missed your periods”, with the Ovulona the detection will be immediate and, importantly, the Ovulona will make it possible to monitor the progress of the pregnancy. Where the doctor writes, “You should get a blood test”, that will no longer be the only option for the woman in the early days of uncertainty about her pregnancy status, or in the subsequent early stage of pregnancy.

The point is this: The hCG level in the blood shows the presence of the conceptus, and the immediate disappearance of the follicular waves is expected to show the presence of the conceptus before the hCG test can. The reason is that the hCG test requires a certain minimal level of the human Chorionic Gonadotropin (hCG) to be reached, and then the blood concentration peaks on the analytical instrument’s readout that the service lab will use.

This is how the pregnancy shows in the lab test for hCG:

Conceptus signature - small

Conceptus signature – small

Figure from Proc. Natl. Acad. Sci. U.S.A. 96 (6): 2678–81 (March 1999)

http://www.pnas.org/content/96/6/2678.figures-only or http://to.ly/OYI

See also http://en.wikipedia.org/wiki/Human_chorionic_gonadotropin, or http://www.webmd.com/baby/human-chorionic-gonadotropin-hcg .

“Once the fertilized egg implants, the developing placenta begins releasing hCG into your blood.” “hCG appears in the blood and urine of pregnant women as early as 10 days after conception” [http://www.nlm.nih.gov/medlineplus/ency/article/003510.htm ].

“In non-pregnant women, hCG levels are normally undetectable. During early pregnancy, the placenta produces hCG and its level in the blood doubles every two to four days” [http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109390.htm ].

Nothing is perfect, and “hCG kits can detect a wide and varying range of different hCG-related molecules in serum or urine samples” rather than just the one molecule they want to detect [http://www.hcglab.com/index.html ].

“The primary role of hCG in the maternal organism is to serve as a signal to the ovary to maintain the corpus luteum, which would regress if it were not rescued by hCG. … It appears that exponentially increasing amounts of hCG are required to prolong the functional lifespan of the corpus luteum, which explains why the corpus luteum survives early pregnancy but regresses during unfertilized menstrual cycles…” [Parry, S, Glob. libr. women’s med., (ISSN: 1756-2228) 2008 http://to.ly/P0z ]. Corpus luteum (yellow body) is defined as a yellow, progesterone-secreting, mass of cells that forms from an ovarian follicle after the release of a mature egg (i.e., ovulation), http://to.ly/P0B . It is what becomes of the follicle after ovulation.

How it works

Against that background, we bring up the following expected effect of conception on the folliculogenesis profile as it is tracked by the Ovulona and used by the woman at home. The data accumulated in the memory of the device will be available for use by her physician and the healthcare system.

Précis: When conception occurs, the normal folliculogenesis process changes due to the developing pregnancy (i.e., due to the conceptus). Conception can only occur upon ovulation, and when it does then the change happens – immediately. The follicular waves that normally occur after ovulation can no longer appear.

Upon conception, the maternal menstrual cycling is overruled, taken over, by the conceptus and the placenta. Conceptus is defined as the product of conception at any point between fertilization and birth. It includes the embryo or the fetus as well as the extra-embryonic membranes [http://to.ly/P0t , conceptus is from Latin, something conceived; see concept].

The disappearance of the follicular waves will be immediate, and easily detectable. Importantly, as with the monitoring of folliculogenesis for the purpose of either achieving or avoiding pregnancy, it will be presented to the woman at home in plain English as “pregnancy detected” on the display of her Ovulona device.

A very important (and unprecedented) additional advantage of our technique is that any loss of the pregnancy will also be detected in the process of continued routine monitoring during the pregnancy. This is advisable because many conceptions end in natural loss, i.e., the early death of the conceptus. E. g., “absence of TLX antigen recognition due to sharing of maternal-paternal TLX antigen profiles may not allow anti-TA1 activity and may lead to subsequent fetal rejection”, http://www.profelis.org/webpages-cn/lectures/reproductive_physiology_2.html (http://to.ly/P1S ).

Seriousness of the EPL problem

Between one quarter and one third of pregnancies may fail hours or days after implantation [  http://www.hcglab.com/hyperglycosylated.htm , citing Prenat. Diagn. 1998;18:1232–40 and J. Endocrinol. 2002; 172: 497-506]. But see also Further References, below, where the incidence is put at 75%+ of all attempts to conceive – the most common complication of human gestation.

In view of the fact that “treatment of women who present with cramping and spotting in the first trimester of pregnancy would be better guided by a sensitive and specific test that would reliably categorize prognoses for pregnancies”, it is worthwhile to speculate as follows. Since “progesterone appeared to be the single most specific biomarker for distinguishing viable from nonviable pregnancies” [Obst. Gynecol. 2000, Vol. 95, Issue 2, pp. 227-231, http://to.ly/P39 ], and in view of our sensor’s mode of operation (and the expected response to conception), we might even speculate that differentiating between viable and non-viable pregnancies might be attempted with our technique, too.

As throughout the whole text in this article, speculate is the key word.

Further References:

Efficiency and Bias in Studies of Early Pregnancy Loss, Clarice R. Weinberg, Irva Hertz-Picciotto, Donna D. Baird and Allen J. Wilcox, Epidemiology, Vol. 3, No. 1 (Jan., 1992), pp. 17-22, http://to.ly/P3s

Early Pregnancy Loss,  http://emedicine.medscape.com/article/260495-overview Note: Chief Editor is Lee P. Shulman, MD – one of bioZhena Corporation’s Board of Medical Advisors.

Excerpted:

Early pregnancy loss is unfortunately the most common complication of human gestation, occurring in at least 75% of all women trying to conceive. Most of these losses are unrecognized and occur before or with the next expected menses. Of those that are recognized, 15-20% are spontaneous abortions (SABs) or ectopic pregnancies diagnosed after the pregnancy is clinically recognized.

The incidence of spontaneous miscarriage is10-15%, whereas the rate of recurrent miscarriage is 3-5%.

Approximately 5% of couples trying to conceive have 2 consecutive miscarriages, and approximately 1% of couples have 3 or more consecutive losses. Early pregnancy loss is defined as the termination of pregnancy before 20 weeks’ gestation or with a fetal weight of

The gestational age at the time of the SAB can provide clues about the cause. For instance, nearly 70% of SABs in the first 12 weeks are due to chromosomal anomalies. However, losses due to antiphospholipid syndrome (APS) and cervical incompetence tend to occur after the first trimester. END QUOTE.

Medline ® Abstracts for References 3-5,7-9 of ‘Spontaneous abortion: Risk factors, etiology, clinical manifestations, and diagnostic evaluation’ http://to.ly/P4e

Citing from one abstract on the list: “Preterm death of the human conceptus is common.”

Conclusion of a 2003 paper from China: We demonstrated substantial EPL in the non-clinically pregnant cycles and a positive relation between EPL and subsequent fertility. EPL = Early Pregnancy Loss. The conception rate per cycle was 40% over the first 12 months.

Conclusion of a 2010 British Medical Journal paper from Scotland: Women who conceive within six months of an initial miscarriage have the best reproductive outcomes and lowest complication rates in a subsequent pregnancy.                          

See it at: http://www.bmj.com/content/341/bmj.c3967.full?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=Bhattacharya&searchid=1&FIRSTINDEX=0&sortspec=date&resourcetype=HWCIT

About the EDD and/or EDC issue, and a request for input from readers

January 11, 2008

EDD stands for Estimated Date of Delivery, while EDC stands for Estimated Date of Confinement (the time of going to hospital for the delivery, “the lying-in of a woman in childbed“).

Seasonality of Google Searches Bears Out These Thoughts And Plans

August and July, October and/or September are the months of the season of most births in the U.S. And Mums-To-Be are rather anxious about the timing of the pregnancy-to-birthing process, gestation.

Just see how, well ahead of the upcoming birth time, the interest in the search term “gestation” peaks every year in April, give or take a month. You can see it at https://www.google.com/trends/explore?date=2004-12-31%202017-01-18&geo=US&q=gestation (search terms: United States, 12/31/04 – 1/18/17, All categories, Web Search). I’ll expand on the seasonality aspect below, after I share some thoughts and plans.

The bioZhena thinking, in one brief sentence, is this: Aim to replace stochastic with deterministic, which is the purpose of our eukairosicTM diagnostic tools. Then the E in EDD and EDC will stand for EXPECTED.

‘Expected’ based on a measured data based computation, as opposed to a subjective recall based physician’s guess. Because, as I say in the very last sentence at the end of this article: Your approaching EDD and EDC are not normalized/relative like those in the statistical graph …

The medical position on the current status of obstetrics can be characterized by the following two papers.

1) Theory of obstetrics: an epidemiologic framework for justifying medically indicated early delivery

[BMC Pregnancy Childbirth. 2007 Mar 28;7:4. Joseph KS, Perinatal Epidemiology Research Unit, Department of Obstetrics & Gynaecology, Dalhousie University, Halifax, Nova Scotia, Canada]

QUOTE: Modern obstetrics is faced with a serious paradox. Obstetric practice is becoming increasingly interventionist … Whereas … mortality declines exponentially with increasing gestational duration, temporal increases in medically indicated labour induction and cesarean delivery have resulted in rising rates of preterm birth and declining rates of post-term birth. … [This] provides a theoretical justification for medically indicated early delivery and reconciles the contemporary divide between obstetric theory and obstetric practice. END QUOTE.

And 2) A re-look at the duration of human pregnancy

[Singapore Med J. 2006 Dec;47(12):1044-8. Bhat RA and Kushtagi P, Department of Obstetrics and Gynaecology, Kasturba Medical College, Manipal, India]

QUOTE: The duration of human pregnancy is arbitrarily taken as 280 days (40 weeks). Foetuses are considered to be at high risk once pregnancy goes beyond the expected date of confinement. … Conclusion: Mean gestational age at the onset of labour for women native to the area of study was 272 days (standard deviation 9 days). Pregnancies beyond a duration of 280 days showed significantly increased perinatal morbidity. It is suggested that there is a need for determining the length of gestation and to compile gestation-wise incidence of … neonatal morbidity indicators for different populations. END QUOTE.

Related medical publications are here.

I will rely on the birthing specialist, Janelle Durham, to verbalize for you the status quo in this aspect of the homo sapiens experience – below. First,

Gestation Period, Gestational Age and OvulonaTM

Per Encyclopedia of Childhood and Adolescence, article Gestation Period and Gestational Age ,

” a gestation period of thirty-eight weeks (266 days) is calculated for women who are pregnant by a procedure such as in vitro fertilization or artificial insemination that allows them to know their exact date of conception.”

The Ovulona women’s healthcare and self-care device from bioZhena will provide to the woman user a very simple means to record the day of any intercourse as a part of her record of the menstrual cyclic profile. In every cycle, whether pregnancy is planned or not. This must become a part of the routine. The information will be electronically recorded along with the daily or almost-daily measurement data inherent in the use of the Ovulona.

With that menstrual cycling history data, this intercourse-timing information will be available for use by the woman’s physician(s). And in due course (contingent on funding) the cervical ring transformation of the Ovulona will remove the need for daily insertion…

Therefore, the routine use of the Ovulona (and of the internally worn HaloTM cervical ring) will provide for an equivalent of the above-referenced 38-week (266 days) calculation available to the women receiving IVF or artificial insemination. This alone should be an improvement on the current way of EDD/EDC assessment. In this context, an investigation should be undertaken into the question of whether any inference can be drawn from the woman’s menstrual cycle history prior to the conceptive (baby-making) intercourse.

Any comments on this would be welcome, even about anecdotal or subjective or tentative observations that may be available. However non-scientific, however tentative, however uncertain an individual answer or input from you may be…

Questions

Questions such as: What evidence is available in medical literature (or maybe in unpublished records?) about the outcomes of the IVF or artificial insemination pregnancies, i.e. about their documented gestation periods? Does the 38 weeks projection work? Always? If not always, can anything be correlated with any deviation?

Has anyone looked at whether there may be an effect of geography in terms of hot vs. cold climate on gestation periods of natives? And perhaps even at whether a gestation-period difference may arise in data at a well-selected locale between winter and summer deliveries (of course only natural, not “medically indicated early deliveries”)?

The complicating effect of first versus subsequent pregnancy has already been noted, of course… That evidence exists for gestational length variability with ethnicity (or race) has been noted, too:

“122,415 nulliparous women with singleton live fetuses at the time of spontaneous labour, giving birth in the former North West Thames Health Region, London, UK. Results: The median gestational age at delivery was 39 weeks in Blacks and Asians and 40 weeks in white Europeans.” [International Journal of Epidemiology 2004, Volume 33, Number 1, pp. 107-113 ].

I am happy to observe that this outcome is not counter-intuitive (because women with ancestors in hot climates seem to tend to shorter gestational age at delivery than those who can be presumed to originate from colder climate conditions).

Conceivably, such a preliminary info, which I am after here, is not forthcoming — and we shall have to try and gather even these preliminary data in a systematic manner when the time comes, but no question asked, nothing learned… Public or private input would be appreciated. (I wrote this request here in 2008.)

Although focused on the very serious complication in pregnancy, A Balancing Act: Ideal Delivery Timing & Chronic Hypertension by Eva Martin, MD is an example of the kind of information that we will need when setting out to start the adaptation of our technology to the challenge of assessing and managing EDD/EDC. Retweeting her piece, I tweeted in April 2017: This is why when the monitoring will better assess EDD/EDC >abandon old Naegele rule.

Dr. Martin has a few videos online on the subject of due dates, and here is one of them (~2 minutes): How to Calculate Your Due Date After A.R.T. –  https://www.youtube.com/watch?v=G4OCSwxTEIg  (in a nutshell: Fertilization + 266 days [38 weeks] as we already noted above, with reference to the Encyclopedia of Childhood and Adolescence).

There in any case does seem to be some, perhaps fairly good, basis for this attempt at a preparation for an introduction of a tool for definitive assessment of EDD and EDC.

Due Dates Paper by Ms. Durham

According to the due dates paper by Janelle Durham, written for Certification with Birth Education in January, 2002 , QUOTE: “some women are aware of when they ovulate, either based on formal methods and record-keeping such as daily temperature checks, or on physical symptoms such as mild pain upon ovulation, or observation of changes in vaginal mucus. Many women know the dates when conception was possible, because they know the dates when they had intercourse during their most recent menstrual cycle.

Due dates can be calculated based on these dates, but many physicians prefer to calculate it from date of last menstrual period. They may only calculate from conception date if conception was medically managed and supervised through techniques such as artificial insemination.

Based on date of last normal menstrual period.

Due dates are typically calculated based upon the date the last menstrual period began, according to the mother’s report. Naegele’s rule assumes that ovulation occurred 14 days after LMP, which is only the case for women with 28 day cycles. Some caregivers will ask their patients for a history of menstrual cycles so that they can adjust this number, as appropriate, for cycles of different lengths or irregular cycles.

It’s also important to consider: recent use of oral contraceptives, and their possible effect on ovulation date; inaccurate memory about when the last period occurred, the possibility of interpreting post-conception ‘spotting’ as a light period, and unrecognized pregnancy losses. These issues all complicate due date prediction, and it’s estimated that nearly 25% of infants who would be classified as preterm birth on the basis of the last normal menstrual period are not preterm. (Cited in Health Canada)” END QUOTE.

At this point, let me translate the one brief sentence I wrote at the top into a less specialist language. Ms. Durham shows a statistical distribution of gestation periods applicable to any woman, and that is the approach I labeled stochastic, because of its statistical nature. I admit, the word is harking back to the days of my postgrad phys chem endeavors, which were mostly endeavours at the time. 🙂 We could also say, probabilistic – two syllables longer, though!

Gestational Age at Birth vs. Weeks since LMP

http://transitiontoparenthood.com/ttp/birthed/duedatespaper.htm

Janelle Durham, for Certification with Birth Education NW. January, 2002.

.

Our Goal – Your Comments

With our eurokairosicTM diagnostic tools, we generally aim to determine the right time, and in the case at hand we propose to provide for a much less fuzzy assessment of the EDD and EDC. After all, precedent exists in the A.R.T. arena, and prerequisites, too, to some extent at least.

In a nutshell: Let’s replace the LMP/Naegele-based approach with a hard data-based technique, applied to each and by each Mom individually.

Again, your comments on and/or answers to the questions above would be useful. Public or private input would be appreciated. [Private to: vaclav@biozhena.com please.]

In any case, for more on this topic see a related post published on December 8, 2010: Saint Nicholas Day, his legend, and our modern day’s prematurity, EDD calculation, gestational age, problem with LMP. We show there data from a study of more than 24.5 thousand pregnancies demonstrating that “most (71.5%) inductions done post-term (> 294 days) according to LMP dates were not post-term if ultrasound scan dates alone are used to calculate the gestational age.”

Vision

It is perfectly reasonable a vision that, in future, an expectant mother’s EDD and/or EDC will be assessed based on her folliculogenesis in vivo (FIV™) data which will include the electronic record of every sexual intercourse. The EDD/EDC will be computed automatically and provided by her own Ovulona Smart Sensor™.

So that, for example, a woman in and native to (or perhaps with ancestry from) a hot climate region might automatically obtain her EDD of 39 weeks when she electronically registers her day of intercourse on her Ovulona. Versus 40 weeks for a white European, consistent with the knowledge base noted above and assuming its validation.

No more uncertainties as in the LMP-based estimation. The bell-shape curve of distribution (such as the Janelle Durham graph above) will be replaced by personalized specifics.

Seasonality of EDC Searches on Google

On June 1, 2015 (at about the time of the year when, statistically, most American expectant mothers are about the last trimester away from their Estimated Date of Delivery and of Confinement) I add the following illustration. It appears to suggest why in May and June each year for the last 6 years there is always a noticeable increase in the viewing statistic of this blog post that you are reading. The interest in the subject of the due dates is up.

Seasonality of Search Google Trends for search term “EDC” 2009 - 2015

See the image better as Single slide – Google Trends for EDC Search 2009 – 2015 e

Check the trend for yourself by moving from the screen shot image to the actual graph online via the link http://v.gd/c2MOyR i.e. http://www.google.com/trends/explore#cat=0-45&q=edc&geo=US&date=1%2F2009%2078m&cmpt=q&tz= . Once online, the Google graph shows (with cursor put on data for different months) the counts of US searches for EDC in the different months. You can change the range of the time period via the Time button, and the country of interest via the Country button. The numbers represent search interest relative to the highest point on the chart. At the time of writing this, it was the number of searches in June 2014 (assigned the maximal relative value of 100).

Move the cursor along the graph to see the values for other months within the examined period. You’ll see the EDC value of 100 in June 2014; in June 2013 the US peak was at 72 counts. The worldwide trend is much like the US trend because the statistics are driven by the overwhelming majority of American searches. E.g. the May 2015 count worldwide is only higher by 7 more searches than the US value of 48; in June 2014 the worldwide count was the same 100 as the US while in June 2013 the worldwide count was 20 counts higher than the US count of 65.

That’s as of June 3, 2015. Might this change later? Well, click http://www.google.com/trends/explore#cat=0-45&q=edc&geo=US&date=1%2F2009%2082m&cmpt=q&tz=Etc%2FGMT%2B6 and see the graph as of September 12, 2015, which does show the June 2015 peak indubitably.

The worldwide count can be obtained via the Country button on the Explore bar in Google Trends (USA was selected here). The data are normalized, relative numbers – you can read up on it… It’s a Google algorithm.

And here now is a January 6, 2017 update of the Google Trends EDC results, showing that the June peak (in search activity for EDC) continues to be there; in June 2016 it stood at 88 while in June 2015 it was 89, as found by placing the cursor on the peak in the online graph (only one data point can be screen-printed as in the image here) – the URL is below the image:

google-trends-edc-12-31-08-to-12-31-16

https://www.google.com/trends/explore?cat=45&date=2008-12-31%202016-12-31&geo=US&q=edc

.

Dear Reader,

Your approaching EDD and EDC – if indeed their coming up is the reason why you are reading this – are not normalized or relative values like those in the statistical graph

— and good luck, all the best from bioZhena!

.

Parturition means birthing (birth) and dystocia a difficult one

January 9, 2008

And what is a parturition alarm?

For these and other entries, see the Alphabet of bioZhena at

https://biozhena.wordpress.com/2007/11/28/the-alphabet-of-biozhena/

Parturition alarm:

This is a concept that has to do with the need to know when labor or delivery is beginning, because the birthing female may be in need of help.

At the time of writing the first Alphabet draft more than five years ago, an Internet search produced only one such technology, a pressure-sensing girth, suitable for the horse breeder only, because it utilizes the fact that the horse mare lies on her side only in the process of parturition. To illustrate, we borrow a nice picture from a more recent publication found in today’s search on parturition alarm, which search still shows a preponderance of equine innovations:

Equine birth alarm

In the originally noted publication, reference was made to some other method that would detect the emergence of the amniotic sac or of the foal from the vulva (vaginal orifice) but that was not a satisfactory solution. In the horse-breeding arena, about 5-6% of births require help. Various approaches to the birth alarm solution have been attempted.

These days, there are quite a few patents etc. found in the parturition alarm search. And even 5 years ago, a patent from New Mexico University should have been found because their intra-vaginal parturition alarm patent (basically for cows) was published in 1987.

In human obstetrics, where most births take place in hospitals, determining the right time of confinement would be very beneficial. bioZhena (and/or its sister company, bioPecus) will investigate our vaginal sensor technology – suitably modified – with a view to developing a parturition alarm applicable to any mammal.

Also relevant in this context is the implication of the Ovulona making available the menstrual cycle (folliculogenesis) data over many months or cycles before conception. This will enable a more accurate anticipation of the EDD, Expected Date of Delivery. You will understand this better below, under Parturition. I highly recommend that you check out Figuring Your Due Date, too – from the Midwife Archives.

Let us put it this way: Since this is the bioZhena blog (and not bioPecus, for veterinary tools), the EDD issue must be addressed first, before any parturition alarm developments. Because we are primarily concerned with the Rerum Naturare Feminina.

And it would still be of great interest to hear from an expert Latinist about the correct way of saying this in plural, the Natural Thing of Women, the Women’s Natural Thing…

This being a reference to /2007/12/16/cervix-uteri-and-seven-or-eight-related-things/ .

Parturition:

The process of giving birth; childbirth. [From Late Latin parturitio, from Latin parturitus, past participle of parturire, to be in labor.]

Parturition is illustrated at http://www.mhhe.com/biosci/esp/2001_saladin/folder_structure/re/m2/s5/ .

The illustration’s legend indicates that physicians usually calculate the gestation period (length of the pregnancy) as 280 days: 40 weeks or 10 lunar months from the last menstrual period (LMP) to the date of confinement, which is the estimated date of delivery of the infant [EDD].

Indubitably, due dates are a little-understood concept:

“Truth is, even if you know the exact date when you ovulated, you still can only estimate the baby’s unique gestational cycle to about plus or minus two weeks” [ http://www.gentlebirth.org/archives/dueDates.html ]. Why should that be? Because of the variability of your menstrual cycle lengths? (They vary even if you do not think so).

Statistically, the gestation time for human babies has a mean of 278 days and a standard deviation of 12 days, an uncomfortably large spread. The old Naegele Rule of a 40-week pregnancy was invented by a Bible-inspired botanist Harmanni Boerhaave in 1744 and later promoted by Franz Naegele in 1812. It is still believed to work fairly well as a rule of thumb for many pregnancies. However, the rule of thumb also suggests: “If your menstrual cycles are about 28 days, quite regular, and this is not your first child, your physician’s dating is probably fine. If your cycles are longer or irregular, or if this is your first child, the due date your physician has given you may be off, setting you up for all kinds of problems” (induction, interventions, C-section among them).

This is where the bioZhena technology can be expected to provide help, making it possible to reckon the EDD with recorded menstrual cycle (folliculogenesis history) data rather than merely with the LMP + 280 days. This, once properly researched, may be expected to have a significant impact on obstetric management. — Any comments?

It is ironic that, in this age of technological medicine, American women worry about their birthing process not being allowed to take its own natural course on account of an ancient method of predicting the EDD.

Ironically, the 40 week dogma – which is the gestational counterpart of the unacceptable calendar method of birth control (the so-called “Vatican roulette”) – does not reconcile the 295+ days of the 10 lunar months; and yet, at the same time, the U.S. has an unusually high perinatal death rate, resulting from high statistics of too early (preterm) labor. Quid agitur? See also under Gestation.

Dystocia or birthing difficulty:

Dystocia is difficult delivery, difficult parturition. From Latin dys-, bad, from Greek dus-, ill, hard + Greek tokos, delivery. Calf losses at birth result in a major reduction in the net calf crop. Data show that 60% of these losses are due to dystocia (defined as delayed and difficult birth) and at least 50% of these calf deaths could be prevented by timely obstetrical assistance. The USDA web site http://larrl.ars.usda.gov/physiology_history.htm is apparently no longer there but when it was it indicated that an electronic calving monitor was being developed to determine maternal and fetal stress during calving. These studies are important since they are leading the way for developing methods to reduce the $800 million calf and cow loss that occurs each year at calving in the USA’s beef herds.

In analogy with the superiority of in vivo monitoring of folliculogenesis versus tracking behavioral estrus (heat), in vivo monitoring of the progress towards parturition must be a priori a more promising approach.

The telemetric version of the BioMeter – the animal version of the Ovulona technology – will hopefully provide a tool for these efforts. Once tested on animals, human use will be a logical extension of the endeavor. (Or endeavour, should it take place in Europe! Smiley…)

Comment about the EDD and/or EDC issue, and request for input:

Again, EDD stands for Estimated Day of Delivery, while EDC stands for Estimated Day of Confinement.

Per Encyclopedia of Childhood and Adolescence, article Gestation Period and Gestational Age [ http://findarticles.com/p/articles/mi_g2602/is_0002/ai_2602000272 ], ” a gestation period of thirty-eight weeks (266 days) is calculated for women who are pregnant by a procedure such as in vitro fertilization or artificial insemination that allows them to know their exact date of conception.”

The Ovulona device from bioZhena will provide to the woman user a very simple means to record the day of any intercourse. In every cycle, whether pregnancy is planned or not. This must become a part of the routine. The information will be electronically recorded along with the daily or almost-daily measurement data inherent in the use of the Ovulona. With that menstrual cycling history data, this intercourse-timing information will be available for optional use by the woman’s physician(s).

Therefore, the routine use of the Ovulona will provide for an equivalent of the above-referenced 38-week (266 days) calculation available to the women receiving IVF or artificial insemination.

This alone should be an improvement on the current way of EDD/EDC assessment.

In addition, an investigation should be undertaken into the question of whether any inference can be drawn from the woman’s menstrual cycle history prior to the conceptive intercourse. Any comments on this would be welcome, even about anecdotal or subjective or tentative observations that may be available already. However non-scientific, however tentative, however uncertain an individual answer or input from you may be…

E.g., do women with more or less regular cycles tend to exhibit a regular gestation period, and vice versa?

And, certainly, what evidence is available in medical literature (or maybe in unpublished records?) about the outcomes of the IVF and/or artificial insemination pregnancies, i.e., about their documented gestation periods? Does the 38 weeks projection work? Always? If not always, can anything be correlated with any deviation?

Do women with distinctly irregular menstrual cycles tend to have non-regular gestation periods?

The complicating effect of first versus subsequent pregnancy has already been noted, of course…

Conceivably, there is no such preliminary info available, and we shall have to try and gather even these preliminary data in a systematic manner, but – no question asked, nothing learned… Public or private input would be appreciated.

Birthday, and how it relates to the bioZhena enterprise – eukairosic™ diagnostic tools

December 28, 2007

Today is a major anniversary related to the bioZhena enterprise. Namely, a round-number (and not small) birthday of the offspring whose begetting had much, if not everything, to do with the inception of the project.

The biologically educated member of the would-be parental team insisted that medical help would have to be the very last resort, as she did not wish to be poked in and subjected to the various medical procedures available in the country of the proud Albion (that, alas, no longer ruled the waves!), where this awakening was going on. The image of what she resented getting into is telling, and it’s not even the whole story.

Woman in stirups sketch

Awakening on the part of said couple, who till then took steps to minimize or theoretically avoid getting in the family way, owing to circumstances. As in too many instances the world over, the “awakening” was left until somewhat too late. I do not wish to talk about age specifics, but you probably know that particularly female fertility (more accurately put, fecundity or fecundability) decreases starting around or even before the Christ’s age, and so – in retrospect – it was no great surprise to find that achieving pregnancy was not as simple as expected. At the time, actually, this was a great surprise…

At the time, yours truly was not an expert in the field that deals with certain practicalities of the most important aspect of life, by which many of us mean procreation, reproduction, and its management. I am referring to some insight into the practicalities on the female side of things procreative, which insight was not there at the time – but the better half knew the basic fundamental that I now delight in referencing as eukairosic.

In a nutshell, the word refers to the right time, opportune time – exactly what we are about the strategic or “right time; the opportune point of time at which something should be done.” A window of opportunity is kairos time.

For more about this, the Wikipedia article can be recommended, at http://en.wikipedia.org/wiki/Kairos . Let’s cite: Kairos (καιρός) is an ancient Greek word meaning the “right or opportune moment,” or “God’s time” [sic; thus said – but this should say “gods’ time”]. The ancient Greeks had many gods, and two words for time, chronos and kairos. While the former refers to chronological or sequential time, the latter signifies “a time in between”, a moment of undetermined period of time in which “something” special happens. What the special something is depends on who is using the word. END QUOTE.

If you visit that article, you will probably understand why I would like to look at the possibility of adopting as our company logo QUOTE a monochrome fresco by Mantegna at Palazzo Ducale in Mantua (about 1510 C.E.) that shows a female Kairos (most probably Occasio)… UNQUOTE.

You will also appreciate that, since we are not theologians, and because “eu-“ is the Greek prefix meaning well or good or true or easy, my choice of the adjective that we want to trademark as descriptive of bioZhena’s wares is eukairosic™.

And so here, for the sake of accurate definition, is one other item from The Alphabet of bioZhena – /2007/11/28/the-alphabet-of-biozhena/

Fecundability and fecundity:

Fecundability is the probability of achieving pregnancy within one menstrual cycle – about 20% or maybe 25% in normal couples [sic; the probability depends on many factors, including age – vide infra, or see below].

Fecundity is the ability to achieve a live birth.

Fecundability is strongly influenced by the age of the partners, and it is maximal at about age 24. There is a slight decline at ages 24 – 30, and a rapid decline after age 30.

The words are derived from Latin fecundus, fecund, from the root of fetus, via Old French fecond. Fecund means fruitful in children, or prolific.

As for the eukairosic diagnostic tools, their utility goes beyond reproductive management. Due to folliculogenesis (menstrual cycling), even things such as administration of medications or certain diagnostic examinations must be performed at the right time within the menstrual cycle…

Scire quod sciendum

fecundoscitus!!! 🙂

Thus spoke the exegete and father of Barnaby and Petrushka, Vaclav Kirsner © 2007

 ‘To know what is to be known’.

Infertility and A.R.T. or Assisted Reproductive Technologies

December 15, 2007

For these and other entries, see the Alphabet of bioZhena at

/2007/11/28/the-alphabet-of-biozhena/

 

 

Infertility:

Clinical infertility is the inability of a couple to achieve a pregnancy or to carry a pregnancy to term after one year of unprotected intercourse. If the difficulty to conceive lasts less than a year, the condition is referred to as reduced fertility or sub-fertility (see the previous post at /2007/12/14/sub-fertility-or-reduced-fertility/ ). Clinical infertility is classified further into male infertility, female infertility, couple infertility, and unexplained infertility. Studies have shown that in the past 50 years the quality and quantity of sperm has dropped by 42% and 50% respectively. In the past 20 years the decrease in sperm counts has occurred at a rate of 2% annually. For further information refer to Xeno-estrogens (see the Alphabet of bioZhena at /2007/11/28/the-alphabet-of-biozhena/ and the web reference therein).

In the U.S. alone, of the 6.7 million women with fertility problems in 1995, 42% had received some form of infertility services. The most common services were advice and diagnostic tests, medical help to prevent miscarriage, and drugs to induce ovulation [Fam. Plann. Perspect. 2000 May-Jun;32(3):132-7].

 

 

 

A Glossary of Infertility Terms and Acronyms published by the InterNational Council on Infertility Information Dissemination is available at http://www.inciid.org/glossary.html .

 

 

ART or Assisted Reproductive Technologies:

 

Also referred to sometimes colloquially as the “heroic procedures”, they are used to treat infertility patients. ART refers to all techniques involving direct retrieval of oocytes (eggs) from the ovary. They are: artificial insemination (AI), IVF (in vitro fertilization), TET (tubal embryo transfer), ZIFT (zygote intra-fallopian transfer), GIFT (gamete intra-fallopian transfer), ICSI (intra-cytoplasmic sperm injection), blastocyst transfer and other infertility treatments, such as IUI (intra-uterine insemination), assisted hatching (AZH), and immature oocyte maturation (IOM).

Web reference: http://www.ebiztechnet.com/cgi-bin/getit/links/Health/Reproductive_Health/Infertility/Education/Assisted_Reproductive_Technologies/

 

 

Sub-fertility or Reduced Fertility

December 14, 2007

For this and other entries, see the Alphabet of bioZhena at

/2007/11/28/the-alphabet-of-biozhena/

Subfertility (THE INITIAL TARGET OF BIOZHENA):

A state of less than normal fertility but not as bad as clinical infertility. Also called reduced fertility, it refers to the inability to conceive for more than about 4 months but not more than a year (which then becomes classified as clinical infertility, the inability to conceive after a year of unprotected intercourse). It is estimated that as many as one in six couples (17%) have difficulty in conceiving the number of children they want when they want them.

Again: Research suggests that between 14 and 17 percent of couples are affected by subfertility at some time during their reproductive lives. In fact, only eight out of 10 couples trying for a baby do get pregnant within 12 months. For approximately 10 percent of couples, pregnancy will still not have occurred after two years (clinical infertility). Sometimes the label of subfertility is used for couples who have had regular unprotected sexual intercourse for all of two years without conception taking place. This is a reflection of the fact that subfertility is becoming more and more commonplace.

According to one source ( http://www.womens-health.co.uk/ ), even for a healthy fertile couple, the ‘per month’ success rate (conception rate) is only around 15-20%, “so it is not at all uncommon to take some months to conceive”. Overall, around 70% of couples will have conceived by 6 months (a 30% subfertility rate). 85% conceive within 12 months (a 15% subfertility rate, “for the less impatient”). And 95% will be pregnant after 2 years of trying (technically, this is a conservatively estimated infertility rate of 5% – c.f. the 10% referenced above; or, this statistic might be perhaps considered the subfertility rate for the angelically patient). The monthly success rate in this population is 8%, and this statistic drops progressively as time goes on.

As for possible causes of difficulty to conceive, alcohol consumption, even in small amounts, can reduce a woman’s chance of conceiving by more than 50 percent, and smoking “…drastically reduced fertility in our sample”, as wrote a team from the Baltimore-based Health Care Financing Administration, in a report published in “Fertility and Sterility” (1998; 70: 632-637).

In terms of help, many people believe that fertility drugs, even when effective, remove conception from the intimate relationship between the partners, which means that it is to some extent beyond their control. Besides this loss of control, there are drawbacks and disadvantages to all forms of medically assisted conception. Some of them have potentially serious long-term effects. Consequently, many couples prefer to avoid these risks.

Women who describe overcoming infertility with the help of alternative therapists went to them because they had been offered drugs to induce ovulation but were reluctant to take them, when they learned of the possible side effects. Disturbing reports have appeared about the long-term as well as short-term effects of assisted conception. Increased miscarriage levels and premature and multiple births are not only very distressing but have considerable cost implications, both personally and societally (i.e., this is a public health issue). Babies born prematurely, or in multiple births, are at a disadvantage from the start. There are also some reports of increased rates of ovarian cancer in women who have taken fertility drugs, and of cancer in the babies of mothers who have had ovulation induced by drugs.

Subfertile couples are naturally interested in methods and tools that can help them to overcome the difficulty to conceive. The endocrinologist professor Brown may be quoted: “Failing to conceive when wanted is stressful and therefore favours infertility. It should be remembered that, apart from a few conditions such as blocked fallopian tubes, absent sperm and continued anovulation, most couples will conceive eventually without help. However, the modern expectation is one of immediate results, and the main function of assisted reproduction techniques is therefore to shorten the waiting time for conception.” To which we would add that bioZhena aims to offer a more affordable and safer alternative.

With the mentioned statistics of the fertile-age women suffering from the subfertility problem, this is a truly large opportunity in a constantly renewing and growing market. We are talking about 9 or 10 or even 18 million women in the USA alone – or quite possibly many more, taking into account all the impatience and demand for instant gratification in people today; plus about 50% of the 10 million of clinically infertile US couples, that is those who cannot afford the very costly ART treatments. [A.R.T. = Assisted Reproductive Technologies.]

This is the initial, early-stage, mission of bioZhena Corporation: To provide a definitive timing aid to couples experiencing difficulties in conceiving a baby. See also the entry for the Ovulona, where it is explained that, in this situation of reduced fertility, the basic problem is the proper timing of the intercourse.

 

BIOZHENA’S MISSION: A HEALTH TOOL FOR EVERY WOMAN

December 10, 2007

Far more than a tool to aid achieving and avoiding pregnancy

In the early years of the project, I published here a modestly formulated version of bioZhena’s vision statement. That was before a female OBGYN physician joined the team and together we broadened the vision and mission.

With the “Ambassador for the Vagina” it became plausible to fully explore the broad applicability of the technology, and to plan pregnancy monitoring and the transformation of the daily-inserted Ovulona into the semi-permanently worn telemetric cervical ring version that Kim the OBGYN named the Halo™.

Friendly Technology - with cervical ring & Ovulograph

For healthcare providers the Ovulograph™, and the Halo™ cervical ring for all women

Our vision is to create a product that practically every woman will want to use. The woman of the 21st century is envisaged to become accustomed to using her daily Ovulona and/or Halo self-check about as routinely as she is using her toothbrush.

It is pertinent to note that a May 2017 Human Factors in Computing Systems study found that the smartphone apps that track menstrual cycles “often disappoint users with a lack of accuracy… and an emphasis on pink and flowery form over function and customization”. Significantly, too, “teenage girls were relying on smartphone apps as their primary form of birth control”. Such evidence indicates that the market is primed for the bioZhena technology breakthrough.

The Ovulona™/Halo™ will be useful to the point of becoming an essential tool of women’s health management, both at home and, when appropriate, via the Ovulograph™, for the provider in the doctor’s office – and for the payer, too. Accordingly, the Ovulona will be supremely user-friendly and affordable for everyone.

See and listen to the slides in the link at the end of the post.

The Ovulona personal fertility status self-diagnosis device

 What is folliculogenesis - like EKG

Applications of cervical sensor girl w. device and other solutions - panorama1

.

Go to New mostly narrated slides 2017

Slide show takes a few moments to open

Fetal sex preselection – illustrated

December 3, 2007

Ovulona and logo

In the document attached to this post (below), we say:

The following illustration is adapted from one of our slides. The slide indicates how baby gender pre-selection works or rather how it will work when the Ovulona™ is launched in the marketplace. The data were generated in a clinical study performed with our early prototype by an independent OBGYN academic. The data show the morning and evening cyclic profiles from one of the baseline subjects studied by the gynecologist Dr. Benedetto of the University of Turin, Italy.

This is a record of one menstrual cycle of a 30-years old woman participating in the Italian clinical test. The record shows the typical features of the Ovulona cyclic profile. In these early tests, the measurements were taken twice daily (morning and evening) in order to see if a time-of-day effect could be observed, and the BBT (Basal Body Temperature) was taken in the usual manner as a reference parameter.

Here is the slide:

The three-day fertile window how-to

The record shows that the features of the cyclic pattern – reproducible because the same features were also obtained by other women – make it possible to determine the boundaries of the fertile window. The precision is such that it allows for correlation of fertile day 1 with trying to conceive a boy, and correlating fertile day 3 (the ovulation day) with trying to conceive a girl. Correlating each of the 3 fertile days with the indicated likely gender of the baby conceived on the given day is based on the results of certain studies by other investigators (John France et al.), as referenced below.

The outcome of their clinical work is consistent with the finding a decade later – by other investigators in 2001 – that male spermatozoa (Y-chromosome-bearing sperm) live longer than female spermatozoa (X-chromosome-bearing). The France et al. results from timed-conception birth-giving patients stand by themselves but it is nice to have available the separately produced physiological rationale that explains those results; read on.

And here is in a nutshell the clinical trial evidence for the 3-day fertile window:

.
3-day window data from a study by John France et al.
.

This is a re-plot of their data (from 55 births) of birth counts as a function of the cycle day, whereby the outlier data points were considered to belong, in fact, to the counts of the three days of high birth counts, the outliers having been due to their inaccurate and unreliable methods of estimating the time of ovulation. The problem will be resolved when, instead of the old imperfect methods of guesstimating ovulation, people will use our Ovulona monitor.

More details are in the attached file: Fetal sex preselection – illustrated

The file is a description of the origin (including the best clinical trial evidence available to date) of the 3-day fertile window.

The 3-day window of high conception probability is unequivocal (there is no doubt that the data show that window). The low birth counts on the flanks of this 3-day group are data point outliers due to errors in the investigators’ estimating the ovulation day.

The 3-day group of high birth counts is in the data whether we simply ignore the outliers or add them to this group. This is no unreasonable massaging of the data because the investigators’ methods of estimating ovulation timing are well known to have high error bars associated with their ovulation-day estimation.

The 3-day fertile window is also supported by evidence published in the NIH paper referenced below. The 3 days of unequivocally high probability of conception are clear in their data, which is all based on analysis of first morning urine samples for metabolites of estrogen and progesterone that they considered “highly concordant with the peak urinary concentration of luteinizing hormone (which corresponds approximately with the day of ovulation)”.

The NIH researchers (Wilcox et al.) did not consider the inaccuracy of their estimated ovulation despite their having acknowledged that their method only “approximately” assessed the timing of ovulation. Unlike France et al., they did not use more than the one method of estimating ovulation. They simply accepted that, in addition to the three days of high conception probability, their data also contained three early days of low probability of conception – as though 3 to 5 days old spermatozoa made a woman a little bit fertile, despite the 3-day maximum lifespan of the sperm.

We account for their days of low conception probabilities in the same way as above, in terms of data point outliers. A probable cause of their low conception probabilities in the early pre-ovulation days (days -5 to -3), additional to their merely approximately estimating ovulation timing, was the possible delay between the indirectly monitored systemic hormone signals and the actual ovulation. Ovulation (day 0) in their study was not detected but only assumed based on urine hormone metabolite measurements. Despite this and other flaws in their study design, the evidence of the 3 days of high conception probability is there, similar to the data of France et al.

The Wilcox et al. technique of tracking certain ovarian hormones in the urine does not monitor the complex mechanism of folliculogenesis. Any mismatch between the ovarian and the brain hormone signals goes therefore undetected, and their estimate of ovulation timing is indeed very approximate. Of the other study design flaws, let’s mention the artifice that any “intercourse recorded on a given morning was assumed to have occurred the previous day”. This incongruous assumption artificially produced the day 1 conception probability of zero.

As for their low probability data for days -5 to -3, we can consider them to be data point outliers because a pilot study with our prototypes produced evidence of ovulation delays of up to 3 days after urinary LH detection (even 4 days in one of the 21 cycle records, monitoring urinary LH, Peak mucus, and Ovulona prototype). Ref.: https://biozhena.wordpress.com/2010/03/28/folliculogenesis-in-vivo%E2%84%A2-monitoring-is-far-better-than-current-home-use-fertility-self-help-tools/

Further, in support of the fetal gender preselection based on fertilization timing, a “statistically significant lower proportion of male births among conceptions that occur during the most fertile time of the cycle”, meaning at or near estimated ovulation, was found in a 1991 Johns Hopkins University meta-analysis of six NFP studies, cited below in the References.

Similar conclusion came out of an assessment of medical literature in 1989: “More females are conceived when coitus occurs relatively close to ovulation…”. The view of the cited group at University of Washington School of Medicine, Seattle was that the “influence of coital timing on the sex ratio is overall quite subtle and is not a practical method to alter the sex ratio for individual couples” (for citation see References). We would say that our purpose is to offer a means with which to make it practical…

Besides the referenced reviews of clinical outcomes, there is the above-mentioned evidence from a premier infertility treatment institute (G. Hodgen et al., see References) that male spermatozoa (Y-chromosome-bearing sperm) live longer than female spermatozoa (X-chromosome-bearing).

Therefore, intercourse two days before ovulation favors the conception of a boy because only the male Y-chromosome bearing spermatozoa live that long. The male sperm live long enough to be available for fertilization when ovulation releases the ovum (egg) from the ovulating ovarian follicle.

Whereas the female X-chromosome bearing spermatozoa have a chance to produce a baby girl only if intercourse takes place on the day of ovulation, because of their short lifespan.

Note that these are probabilistic indications, hence the labeling “try for a boy” and “try for a girl”. Certainly, we would not say that on the given day you will definitely conceive as indicated.

That should be no surprise because you know that conception is a matter of chance, a probabilistic matter, in the first place. More on this topic of conception probability is in the post Difficult conception tied to pregnancy complications – addressed.

.

References

France et al. paper with data on fetal sex pre-selection, 3-day fertile window:

J.T. France, F.M. Graham, L. Gosling, P. Hair and B.S. Knox, “Characteristics of natural conception cycles occurring in a prospective study of sex preselection: fertility awareness symptoms, hormone levels, sperm survival, and pregnancy outcome”, International Journal of Fertility 37 (4), 224 – 255, 1992.

Wilcox et al. NIH paper:

A.J. Wilcox, C.R. Weinberg and D.D. Berg, “Timing of sexual intercourse in relation to ovulation. Effects on the probability of conception, survival of the pregnancy, and sex of the baby”, New England Journal of Medicine 333, 1517 – 1521, 1995.

Hodgen et al. paper on different survival times of X and Y sperm:

Q. Van Dyk, M. C. Mahony and G. D. Hodgen, “Differential binding of X- and Y-chromosome-bearing human spermatozoa to zona pellucida in vitro”, Andrologia, Volume 33, Issue 4, Page 199, July 2001.

Johns Hopkins University meta-analysis of six NFP studies:

R. H. Gray, “Natural family planning and sex selection: fact or fiction?”, American  Journal of Obstetrics and Gynecology 1991 Dec; 165(6 Pt 2):1982-4.

University of Washington School of Medicine review and assessment:

P. W. Zarutskie, C. H. Muller, M. Magone and M. R. Soules, “The clinical relevance of sex selection techniques”, Fertility and Sterility 1989 Dec; 52(6):891-905.



%d bloggers like this: